UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016110 |
|---|---|
| Receipt number | R000018694 |
| Scientific Title | Influence of intraoperative use of remifentanil to postpoerative nausea and vomiting(PONV) |
| Date of disclosure of the study information | 2015/01/05 |
| Last modified on | 2018/09/20 18:00:49 |
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Basic information
Public title
Influence of intraoperative use of remifentanil to postpoerative nausea and vomiting(PONV)
Acronym
Influence of intraoperative use of remifentanilto PONV
Scientific Title
Influence of intraoperative use of remifentanil to postpoerative nausea and vomiting(PONV)
Scientific Title:Acronym
Influence of intraoperative use of remifentanilto PONV
Region
| Japan |
Condition
Condition
upper extremity surgery
Classification by specialty
| Orthopedics | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the influence of intraoperative use of remifentanil to PONV
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence of postoperative nausea
Key secondary outcomes
Respiratory rate at the time of leaving
Time until spontaneous breathing appear
Total dose of remifentanil
End-tidal sevoflurane concentration at the time of awakening
NRS at rest
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The intraoperative use of remifentanil
Interventions/Control_2
The intraoperative nonuse of remifentanil
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with ASA-PS 1-3
Patients who consent
Key exclusion criteria
Patients who did not consent
Patients with allergy of local anesthetics
Pregnant or lactating women
Patients with liver failure or renal failure
Patients with bradycardia(HR<40bpm)
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tatsunori Watanabe |
Organization
Niigata University Medical and Dental Hospital
Division name
Department of Anestesio;ogy
Zip code
Address
Asahimachi 1-757, Chuo-ku, Niigata 951-8510, Japan
TEL
025-227-2328
deepimpact034@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatsunori Wataanbe |
Organization
Niigata University Medical and Dental Hospital
Division name
Department of Anestesio;ogy
Zip code
Address
Asahimachi 1-757, Chuo-ku, Niigata 951-8510, Japan
TEL
025-227-2328
Homepage URL
deepimpact034@yahoo.co.jp
Sponsor or person
Institute
Niigata University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 01 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 12 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 08 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 01 | Month | 05 | Day |
Last modified on
| 2018 | Year | 09 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018694
